Second-line Paclitaxel/Carboplatin Versus Vinorelbine/Carboplatin in Patients Who Have Advanced Non–Small-Cell Lung Cancer Pretreated With Non–Platinum-Based Chemotherapy: A Multicenter Randomized Phase II Study

• Published in: Clinical lung cancer Vol. 12; no. 2; pp. 100 - 105
• Main Authors: Pallis, Athanasios G, Syrigos, Kostas, Kotsakis, Athanasios, Karachaliou, Niki, Polyzos, Aris, Chandrinos, Vassilis, Varthalitis, Ioannis, Christophyllakis, Charalambos, Ardavanis, Alexandros, Vamvakas, Lambros, Vardakis, Nikolaos, Saridaki, Zacharenia, Samonis, George, Giassas, Stylianos, Georgoulias, Vassilis, Agelaki, Sophia
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2011
• Subjects: Adult; Aged; Aged, 80 and over; Anemia; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carboplatin - administration & dosage; Carboplatin - adverse effects; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Disease Progression; Docetaxel/gemcitabine; Drug Administration Schedule; Female; Hematology, Oncology and Palliative Medicine; Humans; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Middle Aged; Neoplasm Staging; Paclitaxel - administration & dosage; Paclitaxel - adverse effects; Pulmonary/Respiratory; Stage IV disease; Survival Rate; Taxoids - administration & dosage; Thrombocytopenia; Treatment Outcome; Vinblastine - administration & dosage; Vinblastine - adverse effects; Vinblastine - analogs & derivatives; Thrombocytopenia; Docetaxel/gemcitabine; PC; Stage IV disease; Anemia; VC
• ISSN: 1525-7304; 1938-0690
• DOI: 10.1016/j.cllc.2011.03.004

Abstract Purpose This study evaluates the activity and toxicity of the paclitaxel/carboplatin (PC) doublet versus vinorelbine/carboplatin (VC) doublet as second-line treatment in patients who have advanced non–small-cell lung cancer (NSCLC). Patients and Treatment Patients pretreated with front-line docetaxel and gemcitabine were randomized to receive either PC (n = 75), which consisted of paclitaxel at a dose of 140 mg/m2 and carboplatin area under the curve (AUC3), or VC (n = 78), which consisted of vinorelbine at a dose of 45 mg/m2 orally and carboplatin AUC3; both drugs were administered on days 1 and 15. Results The overall response rate was 18.6% (95% confidence interval, 9.85%-27.49%; one complete and 13 partial responses) in the PC arm and 7.7% (95% confidence interval, 1.78%-13.61%; one complete and five partial responses) in the VC arm ( P = .056). Median time to tumor progression was 3.5 months (range, 0.3 - 23.73 months) and 3.07 months (range, 0.37-18.5) in the PC and VC arm, respectively ( P = .287). Median overall survival was 7.83 months (range, 0.3-45.03 months) and 7.60 months (range, 0.5-30.27 months) for PC and VC arms, respectively ( P value = .633). Chemotherapy was well-tolerated and grade III/IV toxicities were relatively infrequent. No toxic deaths were observed. Conclusions Platinum-based doublets with either paclitaxel or vinorelbine in patients with advanced/metastatic NSCLC pretreated with front-line docetaxel/gemcitabine show comparable efficacy when used in the second-line setting.